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临床试验/CTRI/2026/04/108005
CTRI/2026/04/108005尚未招募不适用

Effectiveness of Repetitive Transcranial Magnetic Stimulation augmentation of pharmacotherapy in Obsessive Compulsive Disorder

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2026年4月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1

研究概览

简要总结

This study aims to evaluate whether repetitive transcranial magnetic stimulation (rTMS), when added to ongoing standard pharmacotherapy, is more effective than sham rTMS plus pharmacotherapy in reducing the symptoms of obsessive-compulsive disorder (OCD). OCD is a chronic and disabling psychiatric condition characterized by intrusive thoughts (obsessions) and repetitive behaviors (compulsions). Many patients continue to experience significant symptoms despite receiving recommended medications. In this study, 74 patients aged 18 to 55 years, diagnosed with OCD, will be recruited from the outpatient and inpatient services of the Department of Psychiatry, Government Medical College and Hospital (GMCH-32), and Mental Health Institute (MHI). After baseline assessments, participants will be randomly assigned to one of two groups: active rTMS with standard pharmacotherapy or sham rTMS with standard pharmacotherapy. Active rTMS involves the delivery of magnetic pulses over the supplementary motor area to modulate specific brain circuits implicated in OCD. The sham procedure appears identical in setup and sound but does not deliver active magnetic stimulation. Both groups will receive scheduled sessions five days per week for four weeks. Participants will be evaluated at baseline, at the end of the fourth week, and at 10 and 16 weeks using standardized rating scales including the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression (CGI) scale, and Montreal Cognitive Assessment (MoCA). Medication adherence and any adverse effects will be monitored regularly throughout the study period. This study seeks to determine whether augmentation with rTMS results in greater and faster improvement in OCD symptoms and overall functioning compared to pharmacotherapy alone.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 to 55 years.
  • Diagnosis of Obsessive Compulsive Disorder (OCD) as per ICD-11 criteria.
  • Baseline Yale–Brown Obsessive Compulsive Scale (Y-BOCS) score more than or equal to 16 (moderate severity or above).
  • On standard pharmacological treatment (SSRI or clomipramine with or without augmentation with low-dose antipsychotic).
  • Willingness to comply with study procedures and follow-up.

排除标准

  • History of epilepsy, seizures, or significant neurological disorder (e.g., stroke, brain tumour, head injury with loss of consciousness).
  • Presence of metallic implants, pacemaker, cochlear implants, or other contraindications to rTMS.
  • Current comorbid psychotic disorder, bipolar disorder, severe personality disorder, suicidal ideation or recent suicide attempt.
  • Active substance use disorder within the past 6 months, patients currently using Benzodiazepines.
  • Severe or uncontrolled medical illnesses (e.g., cardiovascular disease, uncontrolled hypertension, thyroid disorder).
  • Pregnancy or lactation.

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Somya Tuteja

Government Medical College and Hospital, Chandigarh

研究点 (1)

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